Clinical Trials Register

Summary
EudraCT Number:	2021-000440-22
Sponsor's Protocol Code Number:	Version17032021
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-02-25
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2021-000440-22

A.3

Full title of the trial

Vaccination against COVID-19 in Pregnant and Lactating Women in Belgium

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Vaccination against COVID-19 in Pregnant and Lactating Women in Belgium

A.3.2

Name or abbreviated title of the trial where available

PREGCOVAC.BE

A.4.1

Sponsor's protocol code number

Version17032021

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Universiteit Antwerpen
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sciensano
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universiteit Antwerpen
B.5.2	Functional name of contact point	Investigator
B.5.3	Address:
B.5.3.1	Street Address	Universiteitsplein 1
B.5.3.2	Town/ city	Wilrijk
B.5.3.3	Post code	2160
B.5.3.4	Country	Belgium
B.5.4	Telephone number	003232652862
B.5.5	Fax number	003232652640
B.5.6	E-mail	kirsten.maertens@uantwerpen.be

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Comirnaty
D.2.1.1.2	Name of the Marketing Authorisation holder	BioNTech Manufacturing GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Comirnaty
D.3.2	Product code	J07BX03
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Covid-19 Vaccine Moderna
D.2.1.1.2	Name of the Marketing Authorisation holder	Moderna
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Covid19 Vaccine Moderna
D.3.2	Product code	J07BX03
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	COVID19 Vaccine Astrazeneca
D.2.1.1.2	Name of the Marketing Authorisation holder	Astra Zeneca
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Covid 19 Vaccine AstraZeneca
D.3.2	Product code	J07BX03
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Vaccine responses to COVID19 vaccines administered in pregnant and
lactating women

E.1.1.1

Medical condition in easily understood language

Corona virus vaccine responses in pregnant and lactating women

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The one central question is whether pregnant and lactating women can
develop similar protective immunity against COVID-19 upon vaccination,
without safety issues. This question needs to be answered urgently and
would help the health care workers and in a later stage the general
population to decide whether immunization in pregnancy or in the
postpartum period during lactation is safe and effective.

E.2.2

Secondary objectives of the trial

In this project we will compare vaccination in pregnant women with age
matched non-pregnant women (from the PICOVAC study, see appendix)
and women vaccinated in the postpartum period during lactation. The
primary objectives are to assess the immune response and safety after
administration of COVID-19 mRNA Vaccine BNT162b2
(Comirnaty®;Pfizer-BioNTech), or other vaccines against COVID19
whenever available for administration in our region, in a population of
pregnant women (N=120), age-matched non-pregnant women (120) and postpartum lactating women
(N=100+ 120), also controlled with an existing prospective study group.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Female population older than 18 years.
• Ability to provide informed consent.
• Being vaccinated with a COVID-19 vaccine.
• Intend to be available for follow-up visits through one year
postvaccination.
• Influenza and pertussis vaccination during pregnancy (as per Belgian
recommendations) is allowed.

E.4

Principal exclusion criteria

Serious underlying immunological condition (e.g. immunosuppressive
disease or therapy, human immunodeficiency virus (HIV) infection…).
• Systemic treatment with immune suppressive medication, including
chronic steroid use of > 10 mg prednisone or equivalent.
• Anything in the opinion of the investigator that would prevent
volunteers from completing the study or put the volunteer at risk.

E.5 End points

E.5.1

Primary end point(s)

To investigate the antibody based immune response (ELISA RBD
antibodies (IgG) ) on day 28 after the second vaccination in pregnant
women, age matched control non-pregnant women and postpartum
lactating women. The definition of response will be based on a
serological correlate of protection for COVID-19 based on SARS-CoV-2
spike(S)-protein specific serum IgG antibody levels (in IU/mL or
seroconversion (a≥4-fold increase of the geometric mean concentration
(GMC) of anti-S protein IgG antibodies over baseline)). For those with a
previous COVID infection, the in house multiplex assay from Sciensano
will be performed to discriminate between previous infection and
vaccination

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

E.5.2

Secondary end point(s)

Secondary End Point (repeat as necessary) To investigate the safety of
the COVID-19 vaccines described in pregnant and
lactating women. Both immediate and long term safety data will be
gathered in women and offspring, according to the Global Alignment of
Immunization Safety Assessment in pregnancy (GAIA) definitions.
Safety will be reported in terms of incidence and severity of systemic
adverse events (AEs) during a continuous reporting system. Incidence
and nature of newly occurring immune related AEs of grade≥3 according
to the Common Terminology Criteria for Adverse Events version 5.0
including information on vaccine specific safety.
• To study the duration of the immune response using serology assays
performed on day 7 and 28 after the second dose as well as at 6 months
after the first dose. ELISA RBD antibodies (IgG) will be tested 7 days
after booster dose and the titer of neutralizing antibodies 7 and 28 days
after booster dose;
• To investigate the efficacy of the immune response. This will be
measured by the COVID-19 infection rate based on information collected
through questionnaires on incidence of (PCR-confirmed) SARS-CoV-2
infection within a time-frame of 12 months after the start of the study.
• In depth assessment of the immune response: By measuring the
SARS-Cov2 specific T and B cell response and its evolution and longevity
by sampling blood at different timepoint. B-cell immunity and T-cell
immunity will be measured seven days and 28 days after boost
• To assess the influence of COVID-19 vaccination on breast milk
composition in view of protective antibodies, in women who are
vaccinated in pregnancy and during the postpartum period.
To assess the amount of transported antibodies to spike protein S in the
offspring. Cord blood will be taken to measure the IgG transport.

E.5.2.1

Timepoint(s) of evaluation of this end point

365 days

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

no intervention

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LSLV

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

420

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-02-25.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

420

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

There is no specific post trial treatment foreseen. If necessary, the trial could be amended with a long term follow up period of the population for saftey reasons.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-03-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-02-08

P. End of Trial
P.	End of Trial Status	Ongoing

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